# K221417: CLAROX plus (Model: VX-100)

- Pathway: 510(k) (Traditional)
- Applicant: Vsi Co., Ltd.
- Decided: Sep 13, 2022 after 120 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K945707 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203667: EzRay M (Model: VMX-P300), VATECH Co., Ltd. (2021) Summary page 5.

## Indications for use
CLAROX plus (Model: VX-100) is a portable general-purpose X-ray system that users can operate with one hand. The device uses a fixed X-ray tube current and voltage (kVp) and, therefore, is limited to taking diagnostic X-rays of extremities. It is intended to be used by a qualified and trained clinician on adult patients and pediatrics. It is not intended to replace a radiographic system with variable tube current and voltage (kVp), which may be required for full optimization of image quality and radiation exposure for different exam types.

Source page: https://510kreport.com/device/K221417
Methodology: https://510kreport.com/methodology